Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FLIX-EMS

K-Number: K181419 · 2019-05-14

ApplicantCasgarum Investment, S.L.
Decision Date2019-05-14
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FLIX-EMS is a medical device manufactured by Casgarum Investment, S.L.. It received FDA 510(k) clearance on 2019-05-14 under approval number K181419. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLIX-EMS?

FLIX-EMS is a medical device that received FDA 510(k) clearance on 2019-05-14. It is manufactured by Casgarum Investment, S.L.. The 510(k) number is K181419.

When was FLIX-EMS approved by the FDA?

FLIX-EMS received FDA 510(k) clearance on 2019-05-14, under approval number K181419.

What company makes FLIX-EMS?

FLIX-EMS is manufactured by Casgarum Investment, S.L..

What is the FDA product code for FLIX-EMS?

The FDA product code for FLIX-EMS is NGX.

Related Devices (Code: NGX)

K152420AK Body Toning DeviceAk Beauty Enterprises, LLC K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. K152480Revitive Medic; Revitive MV; Revitive LVActegy , Ltd. K151722Slim UP ULTRAAime Medical, Inc. K172876PowerDot PD-01MSmartmissimo Technologies Pte, Ltd. K172241Tyece OTC EMS System, Model EM35Tyece , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑